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Colace

Physicians Total Care, Inc.




FULL PRESCRIBING INFORMATION

Docusate sodium 100 mg

Stool softener

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 to 72 hours
  • if you are presently taking mineral oil, unless told to do so by a doctor
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative.
    These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions: Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children
12 years and over
take 1-3
capsules daily
children 2 to under
12 years of age
take 1
capsule daily
children under 2 years ask a doctor
  • each tablet contains: sodium 5 mg
    VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Keep tightly closed.

D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, PEG 400, propylene glycol, sorbitol, titanium dioxide

©2009 Purdue Products L.P.

Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431

302112-0B

Additional bar code label applied by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

Colace

100mg





Colace

Colace

docusate sodium CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-2337(NDC:67618-101)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 33
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
polyethylene glycol 400
propylene glycol
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
RED (Two-toned- opaque light beige and clear red) 1 mm RPC;053 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, PLASTIC
2 NDC:54868-2337-2 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2011-11-08


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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